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Effectiveness of a Cognitive Training Program (UMAM Method) in Elderly People Without Dementia

2020년 1월 25일 업데이트: Madrid Salud

Cognitive Training in Elders Without Dementia Using UMAM Method. Genetic, Brain Volume and Cognitive Reserve Predictors: A Randomized Controlled Study

The study is oriented to analyze the effectiveness of a cognitive training method (UMAM) on cognitive functions, subjective memory and mood state in elderly people without dementia. On the other hand, the study aims to examine whether variables such as cognitive reserve (e.g. educational level), APOE genotype and intracranial volume are related to increased benefit after the intervention. The researchers hope to find that greater cognitive reserve, not having the APOE allele ε4, and a greater volume of memory-related brain areas, are associated with better outcomes after the cognitive intervention.

연구 개요

연구 유형

중재적

등록 (실제)

199

단계

  • 해당 없음

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연구 장소

      • Madrid, 스페인, 28006
        • Centro de Prevención del Deterioro Cognitivo

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

60년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Being over 60 years old.
  • Having a global cognitive performance > 23 in the Mini Mental State Examination Test.
  • Having no history of neurological or serious psychiatric disorders (severe psycho-affective disorders and psychosis or other psychiatric disorders like alcoholism).

Exclusion Criteria:

  • Chronic use of anxiolytics.
  • Chronic use of neuroleptics.
  • Chronic use of anticonvulsants.
  • Having hearing or vision impairments that would preclude testing.
  • Magnetic Resonance Imaging (MRI) contraindications.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Experimental Group

The experimental group carried out a 30-session multi-factorial group memory training program (UMAM method), with a frequency of three weekly sessions of 90 minutes each. The training program consists of four modules: 1- Stimulation of cognitive processes; learning and practicing internal memory strategies and solving everyday forgetfulness; 2- Instruction in basic concepts about memory; 3- Intervention on daily living and forgetting experiences, using internal and external strategies to solve everyday memory failures; 4- Metacognition or metamemory: the subjects were to reflect about their cognitive failures by analyzing the causes and variables of those failures.

In addition, the experimental group followed the standard activities in which all users attending the Center are involved (planned interviews, dialogue-conferences, general health recommendations, etc.).

간섭 없음: Control Group
The Control Group followed the standard activities in which all users attending the Center are involved (planned interviews, dialogue-conferences, general health recommendations, etc.).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in general cognition
기간: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in general cognition, assessed with the Mini Mental State Examination Test (MMSE) and the 7 Minutes Test (7M).The score ranges from 0 to 30 points (MMSE) and from 0 to 89 points (7M). In both cases, the higher scores indicate a better outcome.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in verbal memory
기간: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in verbal memory, assessed with the Word List Test of the Wechsler Memory Scale-III. The score ranges from 0 to 48 points. Higher scores indicate a better outcome.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in logical memory
기간: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in immediate and delayed logical memory, assessed with the Logical Memory Test (immediate and delayed units) of the Wechsler Memory Scale-III. The score ranges from 0 to 75 points (immediate units) and from 0 to 50 (delayed units). Higher scores indicate a better outcome.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in visual memory
기간: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in visual memory, assessed with the Rey memory test (form B). The score ranges from 0 to 22 points. Higher scores indicate a better outcome.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in daily memory
기간: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in daily memory, assessed with the Rivermead Behavioral Memory Test. The score ranges from 0 to 24 points. Higher scores indicate a better outcome.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in attentional amplitude
기간: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in attentional amplitude, assessed with the Direct Digit Test of the Wechsler Memory Scale-III. The score ranges from 0 to 16 points. Higher scores indicate a better outcome.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in attentional control
기간: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in attentional control, assessed with the Inverse Digit Test of the Wechsler Memory Scale-III. The score ranges from 0 to 14 points. Higher scores indicate a better outcome.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in attention and processing speed
기간: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in attention, assessed with the Trail Making Test, form A. The score ranges from 0 to 200 points. Higher scores indicate a worse outcome.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in alternating attention and planning
기간: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in alternating attention and planning, assessed with the Trail Making Test, form B. The score ranges from 0 to 400 points. Higher scores indicate a worse outcome.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in naming ability (language)
기간: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in naming ability, assessed with the Boston Naming Test. The score ranges from 0 to 60 points. Higher scores indicate a better outcome.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in verbal fluency (language)
기간: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in phonologic and semantic verbal fluency, assessed with the Phonological Verbal Fluency Test and the Semantic Fluency Test respectively. The score goes from zero onwards (there is no upper limit). Higher scores indicate a better outcome.
This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in subjective memory
기간: This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in Subjective Memory, assessed with the Memory Failures of Everyday Questionnaire.The score ranges from 0 to 56 points. Higher scores indicate a worse outcome.
This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
Change in mood
기간: This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in mood, assessed with the Geriatric Depression Scale. The score ranges from 0 to 15 points. Higher scores indicate a worse outcome.
This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The Cognitive Reserve as a predictor of change.
기간: Cognitive Reserve was assessed in the pre-intervention assessment.
The Cognitive Reserve was assessed with Rami Test. The score ranges from 0 to 25 points.
Cognitive Reserve was assessed in the pre-intervention assessment.
The Genetic Profile as a predictor of change.
기간: The Genetic Profile was assessed in the pre-intervention assessment.
The Genetic Profile was obtained by genetic analysis employing a blood test. APOE gene has been coded as 1 (meaning no ε4 allele), or 0 (for at least one ε4 allele).
The Genetic Profile was assessed in the pre-intervention assessment.
The Brain Volume as a predictor of change.
기간: The Brain Volume was assessed in the pre-intervention assessment.
The Brain Volume (total gray volume, left hippocampus, right hippocampus and total intracranial volume) was assessed by magnetic resonance imaging. Unit of measure: mm3.
The Brain Volume was assessed in the pre-intervention assessment.

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연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

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기본 완료 (실제)

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연구 완료 (실제)

2015년 5월 1일

연구 등록 날짜

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2019년 12월 22일

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2020년 1월 25일

처음 게시됨 (실제)

2020년 1월 29일

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2020년 1월 29일

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